Eligibility

The trial

Local study conflicts

Inclusion Criteria:
All of:

Exclusion Criteria:

If the patient is eligible:

Explain that the patient may be eligible for the EVIS study.

Gain verbal agreement in principle before proceeding. Explain:




Step-by-Step Guide to Recruitment:

In the working hours of the research team:


Out of hours, weekends, and when the research nurse is not available:

Estimated time required to enroll


Eligibility screening

What to do at baseline before randomisation:


Gather documentation

Documents are downloaded from the EVIS website.


Formal consent process

If patient is eligible, please consent using either:

  1. Patient consent
  2. Personal Representative
  3. Professional Representative
  4. Deferred consent (only if other consent not available within 30 minutes).
    The decision to defer consent should be made by a doctor at training level ST4 or above or an associate PI or consultant who has appropriate trial training and this should be clearly documented in the medical
  5. Consent forms are accessed online in the EVIS recruitment pack (Trust login required)

    You may need to open https://wiired.org on a Trust desktop computer to be able to print these documents

Randomisation procedure

  1. Randomisation is carried out on RedCap
    https://redcap.clinicaltrials.ed.ac.u

Carrying out the intervention(s):

Arms:


Post Randomisation Monitoring and Recording

  1. Record the total IV fluids volume delivered.
  2. Record of total IMP delivered and, if delivered, any other vasopressor.
  3. Continuous monitor for extravasation if IMP is peripheral norepinephrine…
  4. Patient going to Intensive Care -continue infusion.
  5. A patient going to a ward can only have the infusion whilst in the ED. Stop the noradrenaline infusion before the patient leaves the ED. Manage Septic shock as per hospital protocol
  6. Send a message to the EMROx team that the patient was enrolled.
  7. Ensure that ongoing monitoring is arranged.
    Whilst the EMROx team can ensure ongoing monitoring when they are present, at weekends it's important that the clinical team ensure that blood tests set out below are arranges for 24h-, 48h- and 72h-post enrolment.
    Whilst an in-patient:

    • 6 hours (+/- 1 hour) post randomisation:
    • Take and record vital signs (including GCS)
    • Record any bloods taken (including lactate) – taking new bloods is OPTIONAL.
    • IMP administration
    • Record total IV fluids given.
    • Record of total IMP delivered and if delivered any other vasopressor.
    • Monitor for adverse effects and serious adverse effects


    • 12 hours (+/- 4 hours) post randomisation:
    • Take and record vital signs (including GCS)
    • Record any bloods taken (including lactate) – taking new bloods is OPTIONAL.
    • IMP administration
    • Record total IV fluids given.
    • Record of total IMP delivered and if delivered any other vasopressor.
    • Monitor for adverse effects and serious adverse effects


    • 24 hour (+/- 6 hours) post randomisation:
    • Take and record vital signs (including GCS)
    • Take routine bloods (FBC, U&E, LFT, Glucose, CRP – lactate is optional).
    • IMP administration
    • Record total IV fluids given.
    • Record of total IMP delivered and if delivered any other vasopressor.
    • Monitor for adverse effects and serious adverse effects


    • 48 hour (+/- 12 hours) post randomisation:
    • Take and record vital signs (including GCS)
    • Take routine bloods (FBC, U&E, LFT, Glucose, CRP – lactate is optional).
    • IMP administration
    • Record total IV fluids given.
    • Record of total IMP delivered and if delivered any other vasopressor.
    • Monitor for adverse effects and serious adverse effects


    • 72 hours (+/- 12 hours) post randomisation:
    • Take and record vital signs (including GCS)
    • Take routine bloods (FBC, U&E, LFT, Glucose, CRP – lactate is optional).
    • IMP administration
    • Record total IV fluids given.
    • Record of total IMP delivered and if delivered any other vasopressor.
    • Monitor for adverse effects and serious adverse effects

Disposition and follow-up:



Links for further information:

Further information